Key result
Switching to generic clopidogrel linked to very late stent thrombosis in a poor metabolizer.
Case Report (n=1)
No
Switching from branded to generic clopidogrel may lead to reduced bioavailability and subsequent stent thrombosis in susceptible individuals such as poor metabolizers.
Potential thrombosis risk after generic clopidogrel switch in poor metabolizers; leaves open bioequivalence questions for CYP2C19 variants.
The U.S. Food and Drug Administration recently approved generic versions of clopidogrel bisulfate which should lower the cost and improve compliance in patients requiring dual antiplatelet therapy post stent placement. However, there is marked inter-individual variability in the metabolism and intestinal absorption of clopidogrel. The different binders and fillers used in the generic versions can possibly affect absorption and reduce the bioavailability of the drug. We report a case of very late stent thrombosis in a patient eight days after the switch to generic clopidogrel bisulfate from branded clopidogrel (Plavix). The patient had received a sirolimus drug eluting stent almost three years prior to presentation and was on chronic dual antiplatelet therapy. Subsequent to the event, she was found to be a poor metabolizer of clopidogrel. Although in most cases the use of generic clopidogrel is efficacious and safe, certain individuals, such as poor metabolizers, might be susceptible to increased clinical events when switching. We suggest any suspected cases should be reported to Medwatch so the clinical relevance could be determined.
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Stoupakis et al. (2014) conducted a case report in Stent thrombosis (n=1). Generic clopidogrel bisulfate vs. Branded clopidogrel (Plavix) was evaluated on Very late stent thrombosis. A 60-year-old female who was a poor metabolizer of clopidogrel developed very late stent thrombosis eight days after switching from branded Plavix to generic clopidogrel bisulfate.
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